With Britain’s exit from the European Union fast approaching, the new arrangements for all aspects of the regulation of pharmaceuticals, medical devices and IVDs between the UK and EU 27 pose major challenges.
The ramifications of Brexit after more than 40 years of ever-deepening integration and alignment across the life science sector will be immense, whatever final form Brexit takes.
This course will enable you to hear the latest information from our expert panel of speakers to help you understand the changes that are required and ensure you are ready as the deadlines approach.
Benefits of attending:
- Hear the latest information on Brexit and how it will affect the life science sector
- Discuss the outstanding issues and what actions need to be taken to prepare for Brexit
- Gain an insight into the MHRA perspective on Brexit
- Consider the specific issues relevant to both the medical technology and pharma industries
- Explore the impact on both existing and new products
Who should attend?
This course will be of interest to anyone within the pharmaceutical or medical technology sectors seeking an update on the impact of Brexit.
Brexit – the MHRA perspective
- Where are we now?
- What are the outstanding Issues?
- What will happen next?
Question and answer session
The medical technology sector – what are the issues and how to operate from 30/3/19
- How Brexit will impact on the implementation of the Medical Device Regulation and the IVD Regulation
- Impact for existing and new products
- Impact on the redesignation of Notified Bodies and of products under the new legislation
- Position of UK-based Authorised Representatives Philip Brown, ABHI
The pharma sector – what actions need to be taken to prepare for Brexit
- The alignment for the approval of new products and changes and variations to existing products
- The supply chain concerns, product release and batch testing
- Transfer of market authorisations for UK authorised products
- Issues where the UK is rapporteur/co-rapporteur – Reference Member State (RMS )
- Position for orphan drugs, paediatrics requirements, exclusivity and intellectual property
- Pharmacovigilance issues including location of the QPPV
- Future clinical trial controls David Jefferys, Eisai
How to operate in the UK post Brexit
- What will the key issues be?
Final discussion session